MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS? NXT STEERABLE INTRODUCER; INTRODUCER, CATHETER

Model Number 408310

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Following an atrial fibrillation ablation procedure using an agilis nxt introducer, patient tissue was adhered to the introducer upon removal.During the atrial fibrillation ablation procedure involving a patient with difficult anatomy, the physician had difficulty maneuvering the agilis nxt introducer and bends were noted in the shaft of the agilis nxt introducer.The introducer remained functioning properly and the case was completed without complication.Post procedure, during removal of the agilis nxt introducer, tissue was adhered to the shaft of the agilis.There were no patient symptoms or complications.The patient was monitored an extra day in the hospital and was discharged without complication.There were no performance issues with any sjm devices involved in the procedure.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible as the lot number of the device was unavailable.Based on the information received, the cause of the reported tissue damage could not be conclusively determined.

• Brand Name: AGILIS? NXT STEERABLE INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4310053
• MDR Text Key: 5132074
• Report Number: 3005188751-2014-00143
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 408310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIOSENSE WEBSTER ACCUSON ICE; BARD STEERABLE DYNAMIC DECA CATHETER; BARD STEERABLE QUAD CATHETER; FAST CATH SWARTZ SL TRASSEPTAL INTRODUCER; REFLEXION SPIRAL CATHETER; BIOSENSE WEBSTER THERMOCOOL CELCIUS CATHETER; BRK TRANSSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Weight: 101